[Comparison of quality of life in patients living with HIV infection through pharmaceutical care according to CMO methodology vs. conventional follow-up. MAS-VIH project]. / Comparación de la calidad de vida en personas que viven con infección por VIH en seguimiento mediante atención farmacéutica según metodología capacidad motivación-oportunidad vs. seguimiento convencional. Proyecto MAS-VIH.

OBJECTIVE: To compare quality of life, in patients living with HIV infection with pharmaceutical care according to the CMO methodology: capacity, motivation and opportunity versus conventional follow-up. METHODS: Longitudinal, prospective, multicenter, health intervention study, conducted between October 2019 and November 2021 in 14 centers throughout Spain. Patients over 18 years of age, receiving antiretroviral treatment and attending the consultations of the participating Pharmacy Services for 1 year were included. Patients who did not have the autonomy to complete the planned questionnaires were excluded. At baseline, participating centers were randomized to continue using the same systematics of work (traditional follow-up) or to implement the CMO model using patient stratification models, goal setting in relation to pharmacotherapy, use of motivational interviewing, as well as longitudinal follow-up enabled by new technologies. The main variable was the difference in the number of dimensions positively affected in each follow-up arm at 24 weeks of follow-up according to the MOS-HIV questionnaire. In the CMO group, the interventions performed the most frequently were recorded. RESULTS: 151 patients were included. The median age was 51.35 years. A significant improvement in quality of life was found at the end of follow-up in the CMO group, reducing the number of patients with negatively affected dimensions (2/11 vs 8/11). The most frequent interventions carried out in the CMO group, according to the taxonomy, were Motivation (51,7%) and review and validation (49,4%). CONCLUSIONS: The quality of life of patients is higher in those centers that develop Pharmaceutical Care based on the CMO methodology compared to traditional follow-up.

[Analysis of the evolution of outpatient pharmaceutical care in hospital pharmacy services in Spain after the implementation and development of the MAPEX initiative]. / Analisis de la evolución de la atención farmacéutica al paciente externo en los servicios de farmacia hospitalaria en España tras la puesta en marcha y desarrollo de la iniciativa MAPEX.

INTRODUCTION AND OBJECTIVE: In 2015, the Spanish Society of Hospital Pharmacy (SEFH) launched the Strategic Map for Outpatient Pharmaceutical Care (MAPEX), with the purpose of adapting the activity offered in Hospital Pharmacy outpatient clinics to the new healthcare context. The aim of the present study was to analyse the evolution of outpatient pharmaceutical care in Hospital Pharmacy Services in Spain in the period 2016-2021 after the implementation and development of the MAPEX initiative. MATERIAL AND METHOD: The implementation and development of the project was carried out by a group of experts from SEFH and consisted of five phases: creation of the structure, consensus conference, situation analysis, development of strategic initiatives and evolutionary analysis. To analyse the evolutionary development, a specific 43-item questionnaire was developed that addressed aspects related to structure, context, integration, processes, outcomes and research and was answered in 2016 and 2021 (in the latter case by adding 3 additional questions). RESULTS: 141 hospitals participated in the status survey in 2016 and 138 in 2021. Significant differences were found in all dimensions analysed. None of the aspects assessed suffered a setback in this period. The most highly rated aspects at the general level were the improvement of the care model (65.0%) and at the local level, the incorporation of non-face-to-face pharmaceutical care (42.8%). Further progress in the coming years in the expansion and practical application of the methodology proposed in the project was considered a priority. CONCLUSIONS: The implementation and development of the MAPEX initiative has had a positive impact in terms of quality of care for outpatient pharmaceutical care in Hospital Pharmacy services in Spain.

Application of CMO (capacity, motivation, and opportunity) methodology in pharmaceutical care to optimize the pharmacotherapy in older people living with HIV. DISPIMDINAC project.

OBJECTIVE: To determine the effectiveness of a pharmaceutical intervention, based on the CMO methodology (capacity, motivation and opportunity), to decrease the prevalence of the PIMDINAC concept (potentially inappropriate medication+drug interactions+non-adherence to concomitant medication) in people living with HIV infection. METHODS: Longitudinal prospective multicenter study, conducted between October 2021 and October 2022. Patients living with HIV older than 65 years, on antiretroviral treatment and concomitant drug prescription were included. Demographic, clinical, and pharmacotherapeutic variables were collected. Pharmaceutical care was provided for6 months according to the CMO model in each patient. The main variable was the percentage of patients who simultaneously fulfilled the PIMDINAC concept, comparing the baseline value with the same value at the end of the study. In addition, the percentage of patient's adherent to concomitant and antiretroviral treatment and the percentage of patients meeting the pharmacotherapeutic targets established for the prescribed medicationat 24 weeks of follow-up were compared. RESULTS: Sixty-eight patients were included. Seventy-two percent were men, with a median age of 68 years. The median number of concomitant drugs was 7. A 60.6% of the patients had polypharmacy. The prevalence of the presence of the PIMDINAC concept decreased significantly (10.3 vs. 0%). In isolation, each of the aspects also decreased significantly (p<0.031). The percentage of patients who met the objectives improved significantly from 48,5 at baseline to 88.2 (p<0.001). CONCLUSIONS: The pharmaceutical intervention based onarmaceutical intervention based on the CMO methodology significantly decreased the prevalence of the PIMDINAC concept and increased the number of patients who achieved the objectives, optimising their pharmacotherapy.

Potentially inappropriate medications according to Marc, STOPP and PRISCUS criteria in a cohort of elderly HIV+ patients. The COMMPI project.

OBJECTIVE: The objective is to determine the prevalence of potentially inappropriate drugs according to the Marc, STOPP, and PRISCUS lists in elderly HIV patients. METHODS: It was an observational, retrospective, and multicenter study. People living with HIV 65 years or older who underwent chronic concomitant treatment were included. Descriptive and multivariate analyzes were performed to study the association between polypharmacy and potentially inappropriate medication compliance. RESULTS: A total of 55 patients were included, 81.8% men and a median age of 69 years (IQR: 67-73). The median number of comorbidities was 3 (IQR: 2-5) and the most frequent pattern of multimorbidity was cardiometabolic (62.9%). The predominant antiretroviral treatment was triple therapy (65.5%). Polypharmacy was present in 70.9% of the patients and 25.5% had major polypharmacy. The most frequent polypharmacy pattern was cardiovascular (69.2%). The percentage of potentially inappropriate medications according to the Marc, STOPP and PRISCUS lists was 65.5%, 30.9% and 14.5%, respectively (p<0.001). Adjusted for age and sex, polypharmacy was not independently associated with potentially inappropriate medication compliance in any of the lists. CONCLUSIONS: Polypharmacy and potentially inappropriate medications have a high prevalence. There is great variability in the percentage according to the list applied. Age, sex, and presence of polypharmacy are not predisposing factors to the presence of potentially inappropriate medications.

[Development of the Q-PEX standard for quality certification of pharmaceutical care for outpatients of Pharmacy services]. / Desarrollo de la norma Q-PEX de certificación de calidad de la atención farmacéutica a pacientes externos de los servicios de Farmacia.

OBJECTIVE: The objective of this study is to describe the process of creation and development of the quality certification standard for pharmaceutical care for outpatients of the Pharmacy services. METHOD: The methodology was carried out by a group of experts from the Spanish Society of Hospital Pharmacy (SEFH) and consisted of three phases: situation analysis, development of the standard and definition of the self-assessment tool and, finally, piloting in several hospitals, determining its feasibility, carrying out a new revision and readaptation. RESULTS: A standard was defined with 118 items distributed in ten areas. Of these, 19 were considered compulsory, 36 basic, 40 medium and 23 advanced. Three levels of certification were established, as well as the definition and percentages of compliance with the requirements. The certification process was divided into two stages, the one of previous preparation and the audit itself, where the initial certification would be covered, with four phases - first three led by the certification Company, and the last one by SEFH and the subsequent follow-up and re-certification audits. Two hospitals piloted the process carried out the piloting of the whole process, both obtaining a basic level after the adoption of measures and corrective actions, after which the final definition of the external evaluation of the standard and the name of the standard was agreed upon «Q-PEX¼, as well as, the registration of the intellectual property of said standard in July-2020. CONCLUSIONS: The standard for certification of the quality of pharmaceutical care for outpatients developed aims to help the continuous advancement of Hospital Pharmacy services.

Influence of CMO pharmaceutical care model-based intervention on readmission rate in high risk HIV patients: the INFARDAR study.

OBJECTIVE: Many studies have indicated that hospitalization and readmissions occur frequently, especially among people living with HIV. The aim of the study was to determine the effectiveness of a programmed and structured pharmaceutical intervention, based on "CMO PC model" to reduce the readmission rate in high-risk HIV patients. METHODS: This was a single-center, prospective study based on a structured health intervention conducted between March-2017 and March-2018 with 12 months of follow-up at outpatient pharmacy services. At discharge, HIV patients included were classified according to the risk of readmission as low or high risk patients, being the latter proposed to participate. The selected patients were randomly assigned to a control group (usual care) or intervention group (including stratification-motivational interview and new technologies: CMO pharmaceutical care). The primary endpoint was readmission rate at one year of follow-up in each group. RESULTS: A total of 39 patients were included. As regards the main variable, in the intervention group, 21,4% (n=3) of patients were readmitted in the first year after discharge vs. 66,7% (n=6) in the control group (p=0,042). CONCLUSIONS: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies has a positive influence to reduce the percentage of readmission in high risk HIV patients.

High level of medication regimen complexity index correlate with worse quality of life in people living with HIV.

OBJECTIVE: People living with HIV (PLWHIV) have now a near-normal life expectancy and thus, a higher risk of polypharmacy. The main objective was to assess the correlation between medication regimen complexity index (MRCI) and quality of life (EQ-5D) and health utilities among PLWHIV patients on ART. METHODS: Observational prospective single-center study including adult PLWHIV on ART from January to March-2020 attended at hospital pharmacy outpatient service according to a Capacity-Motivation-Opportunity (CMO) pharmaceutical care model. RESULTS: A total of 428 patients were included, mean age of 50 ± 10.9 years, 82.2% males. Negative correlation (r2=-0.147; p= 0.0002) between MRCI and EQ-5D was found. Relationship between the comorbidity pattern and quality of life, was also observed. Regarding MRCI, Anxiety/Depression, Pain/discomfort and Self-Care were the dimensions with the worst assessment. CONCLUSIONS: A new multidimensional revised care plan for PLWHIV focussed on optimising overall patient care, not limited to viral load goal achievement alone but also in their pharmacotherapeutic complexity and quality of life is needed.

Beliefs and attitudes about deprescription in older HIV-infected patients: ICARD Project.

OBJECTIVE: HIV population is aging at an earlier age than those uninfected, requiring more non-HIV medications to treat noncommunicable diseases. In the context of chronic HIV infection, the next therapeutic change would be the polymedication control. This paper has the purpose of explore the attitudes of older people living with HIV toward deprescribing. METHODS: This was an observational, prospective and multicenter study conducted from March-April, 2018. People living with HIV (PLWH) on highly active antiretroviral therapy and older than 65 years were included. In addition to demographic and pharmacotherapeutic data, attitudes regarding deprescribing were collected through the "Revised Patients' Attitudes Towards Deprescribing Questionnaire". RESULTS: A total of 42 patients were included in this study. Regarding their attitudes in relation to deprescription, there were three statements with the most consensuses. The first ("I have a good understanding of the reasons I was prescribed each of my medicines") had 91.9% consensus. The second and third questions showed 89.2% consensus in both cases; "Overall, I am satisfied with my current medicines" and "I like to be involved in making decisions about my medicines with my doctors". CONCLUSIONS: This study is the first to explore the beliefs and attitudes of older PLWH in relation to deprescription process. There are positive attitudes regarding medication knowledge but there also is a percentage of patients who had a negative opinion regarding deprescription. We must study and go deeper in our knowledge of techniques that could help us to better understand their preferences, in order to establish effective and successful deprescription strategies.

Prevalence of prescription of the Top-10 drug classes to avoid in elderly people living with HIV in a real practice cohort.

OBJECTIVE: We assessed the prevalence of potentially inappropriate prescriptions (PIP) among older (≥ 65 years) people living with HIV (PLWHIV). Additionally, the secondary objective was to analyse the relationship between pharmacotherapeutic complexity and compliance with STOPP-Beers criteria associated with Top-10 drugs classes to avoid (TOP-10-A) of European AIDS Clinical Society (EACS) guidelines. METHODS: This was a cross-sectional observational single-centre study. PLWHIV aged 65 years-old or over on ART attending at hospital pharmacy outpatient service from December-2019 to March-2020 were included. Patients were classified by age group: 65-69, 70-75 and more than 75 years. Moreover, was analysed the relationship between pharmacotherapeutic complexity and compliance with STOPP-Beers Criteria associated with Top-10-A drugs. RESULTS: A total of 19 individuals were included. Overall polypharmacy was observed in 16 PLWHIV (84.2%). A PIP included Top-10-A was identified in 9 (47.4%) PLWHIV. Benzodiazepines were the most prevalent group of prescribed drugs in 6 patients (30.0%). Complex patients were observed in 57.9% (MRCI index value greater than 11.25). Similarly, the sum of criteria STOPP-Beers was higher in older patients. Student's t test showed the existence of a statistically significant relationship between pharmacotherapeutic complexity and sum of STOPP-Beers Criteria (p <0.05) in elderly PLWHIV. CONCLUSIONS: Prescription of PIPs is highly prevalent in older PLWHIV. Consistent with data, presence of PIPs were associated a presence of higher pharmacotherapeutic complexity and sum of STOPP-Beers Criteria. The basis for a new revised care plan for PLWHIV focussed on optimising overall patient care pharmacotherapeutic complexity and its possible consequences.

Experiencia del paciente en tratamiento con inhibidores de PCSK9 con el modelo de atención farmacéutica Capacidad-Motivación-Oportunidad (CMO) / Patient experience in treatment with PCSK9 inhibitors based on the pharmaceutical care model Capacity-Motivation-Oportunity (CMO)

Objetivo: Evaluar la experiencia del paciente crónico tratado con inhibidores de PCSK9 de una cohorte de práctica clínica real según el modelo de atención farmacéutica (AF) basado en el concepto Capacidad-Motivación-Oportunidad (CMO). Métodos: Estudio unicéntrico, transversal, que incluyó pacientes adultos con hipercolesterolemia en tratamiento con cualquier inhibidor PCSK9 que llevaran, al menos, 6 meses de tratamiento y acudieron a seguimiento en consultas externas de AF durante el mes de abril de 2019. Se recogieron variables demográficas (sexo y edad), clínicas (niveles de colesterol total y c-LDL), farmacoterapéuticas (número de medicamentos concomitantes prescritos y tipo de anti-PCSK9) y relacionadas con AF (nivel de estratificación según Modelo de Selección y Atención Farmacéutica de Pacientes Crónicos de la Sociedad Española de Farmacia Hospitalaria). La valoración de la experiencia del paciente se realizó mediante el cuestionario IEXPAC vía telefónica, por un farmacéutico diferente al que realizaba el seguimiento. Resultados: Se incluyeron 28 pacientes (67,9% varones), con una mediana de edad de 63 años (RIQ: 54-72). Los datos farmacacoterapéuticos muestran una población polimedicada. El 80,7% estaba en tratamiento con alirocumab y el 19,3% evolocumab. Mediante el concepto de Capacidad se estratificó la población en estudio resultando un 57,2% de nivel 3, mientras que un 21,4% pertenecían a los niveles 1 y 2 respectivamente. El cuestionario IEXPAC nos arrojó una puntuación global elevada (6,9±1,6). Conclusiones: La evaluación de la atención farmacéutica basada en la metodología CMO en pacientes crónicos en tratamiento con inhibidores PCSK9 cumple una alta expectativa en cada punto de interacción identificado. (AU)

Objective: To evaluate the experience of the chronic patient treated with PCSK9 inhibitors of a cohort of real clinical practice according to the pharmaceutical care model (AF) based on the concept Capacity-Motivation-Opportunity (CMO).Methods: One-way cross-sectional study that included adult patients with hypercholesterolemia in treatment with any PCSK9 inhibitor who took at least 6 months of treatment and who followed up in external AF consultations during the month of April 2019. Demographic variables (sex and age), clinics (levels of total cholesterol and LDL-c), pharmacotherapeutic (number of prescribed concomitant medications and type of anti-PCSK9) and related to AF (level of stratification according to the Chronic Patient’s Selection and Pharmaceutical Care Model Spanish Pharmacy Hospital). The assessment of the patient’s experience was carried out through the IEXPAC questionnaire via telephone, by a pharmacist different from the one who followed up.Results: 28 patients (67.9% male) were included, with a middle age of 63 (IQR: 54-72). Pharmaco-therapeutic data show a polymedicated population. 80.7% were treated with alirocumab and 19.3% evolocumab. Through the concept of Capacity, the study population was stratified resulting in 57.2% of level 3, while 21.4% belonged to levels 1 and 2 respectively. The IEXPAC questionnaire gave us a high overall score (6.9±1.6).Conclusions: The evaluation of pharmaceutical care based on the CMO methodology in chronic patients treated with PCSK9 inhibitors meets a high expectation level at each identified interaction point. (AU)

Determination of a cutoff value for medication regimen complexity index to predict polypharmacy in HIV+ older patient.

OBJECTIVE: HIV+ patients have increased their life expectancy with a parallel increase in age-associated co-morbidities and pharmacotherapeutic complexity. The aim of this study was to determine an optimal cutoff value for Medication regimen complexity index (MRCI) to predict polypharmacy in HIV+ older patients. METHODS: A transversal observational single cohort study was conducted at a tertiary Hospital in Spain, between January 1st up to December 31st, 2014. Patients included were HIV patients over 50 years of age on active antiretroviral treatment. Prevalence of polypharmacy and it pattern were analyzed. The pharmacotherapy complexity value was calculated through the MRCI. Receiver operating characteristic curve analyses were used to calculate the area under the curve (AUC) for the MRCI value medications to determine the best cutoff value for identifying outcomes including polypharmacy. Sensitivity and specificity were also calculated. RESULTS: A total of 223 patients were included. A 56.1% of patients had polypharmacy, being extreme polypharmacy in 9.4% of cases. Regarding the pattern of polypharmacy, 78.0% had a cardio-metabolic pattern, 12.0% depressive-psychogeriatric, 8.0% mixed and 2.0% mechanical-thyroidal. The ROC curve demonstrated that a value of medication complexity index of 11.25 point was the best cutoff for predict polypharmacy (AUC=0.931; sensitivity= 77.6%; specificity=91.8%). CONCLUSIONS: A cut-off value of 11.25 for MRCI is proposed to determine if a patient reaches the criterion of polypharmacy. In conclusion, the concept of polypharmacy should include not only the number of prescribed drugs but also the complexity of them.

Influence of pharmacist intervention, based on CMO model, to improve activation in HIV patients.

OBJECTIVE: The aim of study was to evaluate the influence of pharmacist intervention based on "CMO model", to improve activation in HIV-patients. METHODS: Longitudinal, prospective, single-center study. Eligible patients were HIV-infected, taking antiretroviral treatment. The collected data included demographic characteristics, clinical and HIV-related and pharmacotherapeutic variables. The primary outcome was the variation of patient activation measured by Spanish adapted patient activation measure questionnaire. This questionnaire assesses people's knowledge, skills and confidence in managing their own health care. The assessment was performed at the beginning and 6 months after the program start, which consisted of individualized interventions planned in the stratification model, a motivational interview and a specific pharmacotherapeutic follow-up. RESULTS: A total of 140 patients were included. The most common regimens prescribed were based on non-nucleoside plus nucleoside reverse transcriptase inhibitor (44.0%) and more than half of the patients had chronic concomitant medication. The patients who achieved the highest activation level increased from 28.1% to 68.3% (p<0.0005). The relationship between this increase in patient activation and the stratification level that occurs in largest increases in patients with a low need level, where it was observed an improvement in the percentage of patients with high activation from 28.3% to 74.3% (p<0.001) after intervention. The percentage of patients with adequate adherence to concomitant treatment increased by 18.4% (p = 0.035). Baseline PAM values showed high activation for 28.6% (40 patients), intermediate for 43.6% (61) and low for 27.9% (39). CONCLUSIONS: CMO model has an important role for patient activation, improving adherence and health outcomes for HIV+ patients.

[Evolution of the Complexity Index of the antiretroviral therapy in HIV+ patients in a real life clinical practice]. / Evolución del índice de complejidad de la terapia antirretroviral en paciente VIH en una cohorte de práctica clínica real.

OBJECTIVE: HIV infection has been one of the biggest successes in the healthcare world, mainly due to the appearance of antiretroviral treatment (ART). The complexity of this type of treatment has been one of the decisive factors in the follow-up of these patients. METHODS: An analytical, unicentric, retrospective observational study. We included all patients older than 18 years of age who were diagnosed with HIV who received ART in follow-up for the consultation of pharmaceutical pathology care during the year 2015. The evolution of the complexity index of ART over time and its relation with adherence to ART and concomitant treatment. RESULTS: A total of 619 patients were included in the study with a mean age of 47.03 ± 10.18 years. There was a reduction in CI over the years, with a significant decrease in the year 2013 and in 2015. The results obtained after the analysis of the secondary variables showed a significant relation between the adhesion to the ART and the CI of this. Patients have a lower CI (3.5) than non-adherent patients (4.25). (P = 0.003). CONCLUSIONS: The complexity of ART is being reduced mainly by new treatment strategies and the increasing appearance of pharmaceutical coformulations. A reduction in the complexity of ART assumes a better adherence to it.

[Adherence, satisfaction and health-related quality of life in HIV-infected patients with antiretroviral therapy in Spain. The ARPAS study]. / Adherencia, satisfacción y calidad de vida relacionada con la salud en pacientes infectados por el VIH con tratamiento antirretroviral en España. Estudio ARPAS.

OBJECTIVE: To determine the relationship between satisfaction with antiretroviral therapy (ART), adherence and quality of life (QoL) in adult patients diagnosed with HIV infection and ART according to the posologic load. METHOD: Multicenter, observational and cross-sectional study. Socio-demographic, clinical and of posologic load (1, 2-4 or > 4 tablets/day), adherence (SMAQ, dispensation recordings (DR) and visual analogical scale), satisfaction (ESART questionnaire) and QoL (MOS-HIV) variables were gathered. An adherent patient was defined as the one presenting simultaneously adherence according to SMAQ and DR > 95%. RESULTS: 328 patients (76% men; 46.0 ± 9.2 years) were evaluated. The posology of 1 tablet/day, 2-4 tablets/day and > 4 tablets/day occurred in 29%, 37% and 34% of the patients, respectively. Although the evaluation performed through the SMAQ questionnaire and the VAS scale independently showed statistically significant differences in favor of the 1 tablet/day scheme, the percentage (49%) of adherent patients according to the combined variable did not differ between the groups based on the posologic load. The satisfaction with ART and QoL were high in the three groups, being the 1 tablet/day scheme the one related with higher satisfaction and lower rate of adverse effects on fat metabolism. There were no differences in patients' satisfaction by the adherence level. CONCLUSIONS: Adherence, satisfaction with ART and QoL of the patients with ART are high. Although higher in patients taking 1 tablet/day, the satisfaction did not differ according to the level of adherence and no correlation was observed between satisfaction with ART and quality of life.

OBJETIVO: Determinar la relación entre satisfacción con el tratamiento antirretroviral (TAR), adherencia y calidad de vida (CV) en pacientes adultos diagnosticados de infección por VIH con TAR según la carga posológica. MÉTODO: Estudio observacional, transversal, multicéntrico. Se recogieron variables sociodemográficas, clínicas, carga posológica (1, 2-4 o más de 4 comprimidos al día), adherencia (SMAQ, registros de dispensación (RD) y escala visual analógica), de satisfacción (cuestionario ESTAR) y de CV (MOS-HIV). Se definió paciente adherente cuando simultáneamente presentaba adherencia según SMAQ y un RD > 95%. RESULTADOS: Se evaluaron 328 pacientes (76% varones; 46,0 ± 9,2 años). El esquema de 1c/día, 2-4 c/día y > 4 c/día se dio en el 29%, 37% y 34% de los pacientes respectivamente. Pese que la evaluación realizada por el cuestionario SMAQ y la escala EVA de forma independiente muestra diferencias estadísticamente significativas a favor del esquema 1c/día, el porcentaje de pacientes adherentes según la variable combinada (49%) no difiere entre los grupos en función de la carga posológica. La satisfacción al TAR y fueron elevadas en los tres grupos, siendo los esquemas 1 c/día los relacionados con mayor satisfacción y menores efectos adversos del metabolismo de las grasas. No se observaron diferencias en la satisfacción de los pacientes según la adherencia. CONCLUSIONES: La adherencia, la satisfacción al TAR y de los pacientes con TAR es alta. La satisfacción, mayor en pacientes que toman 1 c/día, no difiere en función de la adherencia y no se observó correlación entre satisfacción con el TAR y calidad de vida.

Adherencia, satisfacción y calidad de vida relacionada con la salud en pacientes infectados por el VIH con tratamiento antirretroviral en España. Estudio ARPAS / Adherence, satisfaction and health-related quality of life in HIV-infected patients with antiretroviral therapy in Spain. The ARPAS study

Objetivo: Determinar la relación entre satisfacción con el tratamiento antirretroviral (TAR), adherencia y calidad de vida (CV) en pacientes adultos diagnosticados de infección por VIH con TAR según la carga posológica. Método: Estudio observacional, transversal, multicéntrico. Se recogieron variables sociodemográficas, clínicas, carga posológica (1, 2-4 o más de 4 comprimidos al día),adherencia (SMAQ, registros de dispensación (RD) y escala visual analógica), de satisfacción (cuestionario ESTAR) y de CV (MOS-HIV). Se definió paciente adherente cuando simultáneamente presentaba adherencia según SMAQ y un RD > 95%. Resultados: Se evaluaron 328 pacientes (76% varones; 46,0 ± 9,2 años). El esquema de 1c/día, 2-4 c/día y > 4 c/día se dio en el 29%, 37% y 34% de los pacientes respectivamente. Pese que la evaluación realizada por el cuestionario SMAQ y la escala EVA de forma independiente muestra diferencias estadísticamente significativas a favor del esquema 1c/día, el porcentaje de pacientes adherentes según la variable combinada (49%) no difiere entre los grupos en función de la carga posológica. La satisfacción al TAR y fueron elevadas en los tres grupos, siendo los esquemas 1 c/día los relacionados con mayor satisfacción y menores efectos adversos del metabolismo de las grasas. No se observaron diferencias en la satisfacción de los pacientes según la adherencia. Conclusiones: La adherencia, la satisfacción al TAR y de los pacientes con TAR es alta. La satisfacción, mayor en pacientes que toman 1 c/día, no difiere en función de la adherencia y no se observó correlación entre satisfacción con el TAR y calidad de vida (AU)

Objective: To determine the relationship between satisfaction with antiretroviral therapy (ART), adherence and quality of life (QoL) in adult patients diagnosed with HIV infection and ART according to the posologic load. Method: Multicenter, observational and cross-sectional study. Socio-demographic, clinical and of posologic load (1, 2-4 or > 4 tablets/day), adherence (SMAQ, dispensation recordings (DR) and visual analogical scale), satisfaction (ESART questionnaire) and QoL (MOS-HIV) variables were gathered. An adherent patient was defined as the one presenting simultaneously adherence according to SMAQ and DR > 95%. Results: 328 patients (76% men; 46.0 ± 9.2 years) were evaluated. The posology of 1 tablet/day, 2-4 tablets/day and > 4 tablets/day occurred in 29%, 37% and 34% of the patients, respectively. Although the evaluation performed through the SMAQ questionnaire and the VAS scale independently showed statistically significant differences in favor of the 1 tablet/day scheme, the percentage (49%) of adherent patients according to the combined variable did not differ between the groups based on the posologic load. The satisfaction with ART and QoL were high in the three groups, being the 1 tablet/day scheme the one related with higher satisfaction and lower rate of adverse effects on fat metabolism. There were no differences in patients' satisfaction by the adherence level. Conclusions: Adherence, satisfaction with ART and QoL of the patients with ART are high. Although higher in patients taking 1 tablet/day, the satisfaction did not differ according to the level of adherence and no correlation was observed between satisfaction with ART and quality of life (AU)

[New drugs in the treatment of chronic hepatitis C]. / Nuevos fármacos en el abordaje terapéutico de la hepatitis C.

OBJECTIVES: To analyze the efficacy and safety of the new direct antiviral agents (DAA) that will become the new therapeutic arsenal for the treatment of hepatitis C. METHODS: We carried out a research in the electronic database with the following criteria: phase II and III clinical trials (CT) published until February 2014. The Mesh term used was "chronic hepatitis C" and "therapy".Studies with boceprevir or telaprevir were excluded. For the analysis of efficacy, we evaluated the rate of Sustained Viral Response(SVR), and for the safety, side effects and safety-related discontinuations were analyzed. RESULTS: We included 24 CT that include associations with ribavirine(RBV) with or without peginterferon (PegINF) and associations of several DAA. The results associated of daclatasvir with PegINF and RBV have not been very successful. On the contrary, sofosbuvir presents activity in all viral genotypes . Sofosbuvir may be administered in free PegINF regimens. Around 90% of naïve patients achieve sustained virological response (RVS) and 80% in previously treated. In relation to second wave of NS3/4A protease inhibitors, simeprevir has achieved RVS in 90% of naïve patients and close to 80% in previously treated.The main combination of DAA were sofosbuvir and daclatasvir and sofosbuvir and ledipasvir. Both have achieved SVR in 100% of patients who previously had virological failure after receiving a protease inhibitor regimen with boceprevir or telaprevir. CONCLUSIONS: The new generation of AAD for the treatment of hepatitis C will lead to higher response rates in all subtypes of patients with lower complexity regimens and better tolerated.

Objetivos: Analizar la eficacia y seguridad de los nuevos agentesantivirales directos (AAD) que formaran parte del arsenal terapéuticopara el tratamiento de la hepatitis C.Método: Se realizó una búsqueda en la base de datos electrónicaPubMed, de artículos publicados Febrero de 2014 quecumplieran los siguientes criterios: ensayos clínicos (EC) en faseII o III y cuyos objetivos fueran evaluar la eficacia y seguridad denuevas generaciones de inhibidores de la proteasa (IP) frente alVHC, excluyendo con boceprevir y telaprevir.Resultados: Se incluyeron de 24 EC que incluyen asociacionesde AAD con ribavirina (RBV) y con o sin peginterferon (PegINF)y asociaciones de varios AAD. Los resultados de daclatasvircon PegINF y RBV no han sido muy satisfactorios. Por el contrario,sofosbuvir es activo en todos los genotipos virales y permiteser administrado en regímenes libres de PegINF. Alrededordel 90% de los pacientes naïve alcanzan respuesta viralsostenida (RVS) , y no llegan al 80% en pretratados. En cuantoa la segunda generación de IP NS3/4A, destacar a simeprevir,con respuestas próximas al 90% en pacientes naïve y cercanasal 80% en pretratados. Entre las combinaciones de AAD evaluadas,sofosbuvir y daclatasvir y sofosbuvir y ledipasvir alcanzanel 100% de respuesta en no respondedores a triple terapiacon boceprevir y telaprevir.Conclusiones: Las nuevas generaciones de AAD frente al VHCvan a suponer un aumento de las tasas de curación en todoslos subtipos de pacientes, a través de regímenes más sencillosy mejor tolerados.

Nuevos fármacos en el abordaje terapéutico de la hepatitis C / New drugs in the treatment of chronic hepatitis C

Objetivos: Analizar la eficacia y seguridad de los nuevos agentes antivirales directos (AAD) que formaran parte del arsenal terapéutico para el tratamiento de la hepatitis C. Método: Se realizó una búsqueda en la base de datos electrónica PubMed, de artículos publicados Febrero de 2014 que cumplieran los siguientes criterios: ensayos clínicos (EC) en faseII o III y cuyos objetivos fueran evaluar la eficacia y seguridad de nuevas generaciones de inhibidores de la proteasa (IP) frente al VHC, excluyendo con boceprevir y telaprevir. Resultados: Se incluyeron de 24 EC que incluyen asociaciones de AAD con ribavirina (RBV) y con o sin peginterferon (PegINF)y asociaciones de varios AAD. Los resultados de daclatasvir con PegINF y RBV no han sido muy satisfactorios. Por el contrario, sofosbuvir es activo en todos los genotipos virales y permite ser administrado en regímenes libres de PegINF. Alrededor del 90% de los pacientes naïve alcanzan respuesta viralsostenida (RVS) , y no llegan al 80% en pretratados. En cuanto a la segunda generación de IP NS3/4A, destacar a simeprevir, con respuestas próximas al 90% en pacientes naïve y cercanas al 80% en pretratados. Entre las combinaciones de AAD evaluadas, sofosbuvir y daclatasvir y sofosbuvir y ledipasvir alcanzan el 100% de respuesta en no respondedores a triple terapia con boceprevir y telaprevir. Conclusiones: Las nuevas generaciones de AAD frente al VHC van a suponer un aumento de las tasas de curación en todos los subtipos de pacientes, a través de regímenes más sencillos y mejor tolerados (AU)

Objectives: To analyze the efficacy and safety of the new direct antiviral agents (DAA) that will become the new therapeutic arsenal for the treatment of hepatitis C. Methods: We carried out a research in the electronic database with the following criteria: phase II and III clinical trials (CT) published until February 2014. The Mesh term used was “chronic hepatitis C” and “therapy”. Studies with boceprevir or telaprevir were excluded. For the analysis of efficacy, we evaluated the rate of Sustained Viral Response(SVR), and for the safety, side effects and safety-related discontinuations were analyzed. Results: We included 24 CT that include associations with ribavirine(RBV) with or without peginterferon (PegINF) and associations of several DAA. The results associated of daclatasvir with PegINF and RBV have not been very successful. On the contrary, sofosbuvir presents activity in all viral genotypes . Sofosbuvir may be administered in free PegINF regimens. Around 90% of naïve patients achieve sustained virological response (RVS) and 80% in previously treated. In relation to second wave of NS3/4A protease inhibitors, simeprevir has achieved RVS in 90% of naïve patients and close to 80% in previously treated. The main combination of DAA were sofosbuvir and daclatasvir and sofosbuvir and ledipasvir. Both have achieved SVR in 100% of patients who previously had virological failure after receiving a protease inhibitor regimen with boceprevir or telaprevir. Conclusions: The new generation of AAD for the treatment of hepatitis C will lead to higher response rates in all subtypes of patients with lower complexity regimens and better tolerated (AU)

A better regulation is required in viral hepatitis smartphone applications / Necesidad de una mayor regulación en aplicaciones para smartphone sobre hepatitis virales

Aim: To describe the characteristics and content of the available viral hepatitis mobile applications, as well as assess the level of participation of medical professionals in their development. Methods: A descriptive observational study was carried out in September 2013. We searched smartphone apps specifically relating to the viral hepatitis for using a keyword search with the following terms; "hepatitis", "hepatology", "hbv" and "hcv" in the Google Play Store (Android) and the Apple App Store (iOS). Data recorded included: name, platform, category, cost, user star rating, number of downloads, date the app was updated by the developer and target audience. We analysed the content of the applications, and these were then categorised based on the viral hepatitis type into three groups. We conducted an analysis in which we specifically examined the authorship in order to assess the prevalence of health professional participation in their development. Results: A total of 33 apps were included (from 232 that were identified), among which there were 10 duplicates. Most of these apps were uploaded under the medical category. Three had ratings less than 3.9 stars (out of 5). Only 6 apps had exceeded 1000 downloads. A total of 12 apps were aimed at health professionals, while 4 focused on patients (7 for both of them). The participation of health professionals in the development of apps was 56.6%. Conclusions: Viral hepatitis apps are available for both professionals and patients; however, much of the information contained within them is often not validated. They should be certificated

Objetivo: Describir las características y el contenido de aplicaciones móviles disponibles sobre hepatitis vírica, así como el nivel de participación de los profesionales médicos en su desarrollo. Métodos: Se realizó un estudio observacional descriptivo en septiembre de 2013. Buscamos en la tienda Google Play (Android) y en la tienda Apple App (iOS) aplicaciones para teléfonos inteligentes que se relacionasen específicamente con la hepatitis vírica empleando una búsqueda por palabras claves que incluía los siguientes términos: 'hepatitis', 'hepatología', "HBV" y 'HCV'. Los datos recogidos incluían: nombre, plataforma, categoría, coste, puntuación del usuario por estrellas, número de descargas, fecha en la que el creador actualizó la aplicación y público objetivo. Analizamos el contenido de las aplicaciones y se distribuyeron en 3 categorías en función del tipo de hepatitis vírica. Realizamos un análisis en el que se examinó específicamente la autoría con el fin de evaluar la prevalencia de la participación de los profesionales sanitarios en su desarrollo. Resultados: Se incluyó un total de 33 aplicaciones (de 232 identificadas), de las cuales 10 estaban duplicadas. La mayoría de las aplicaciones se subían en la categoría médica. Tres tuvieron puntuaciones menores de 3,9 estrellas (de 5 posibles). Sólo 6 aplicaciones superaban las 1000 descargas. Un total de 12 aplicaciones estaban dirigidas a profesionales sanitarios mientras que 4 se centraban en los pacientes (7 para ambos colectivos). La participación de los profesionales sanitarios en el desarrollo de las aplicaciones fue del 56,6%. Conclusiones: Existen aplicaciones disponibles sobre hepatitis vírica tanto para profesionales sanitarios como para pacientes; sin embargo, la mayor parte de la información contenida en ellas a menudo no está validada. Deberían estar certificadas